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Exercise + Liraglutide for Metabolic Syndrome (ZQL008 Trial)
Phase 4
Recruiting
Led By Zhenqi Liu, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meet 3 of 5 National Cholesterol Education Program Adult Treatment Panel III Metabolic Syndrome criteria: Increased waist circumference (≥102 cm in men; ≥88 cm in women), Elevated triglycerides (≥150 mg/dl), Reduced HDL-cholesterol (<40mg/dl in men, <50 mg/dl in women), High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic), Elevated fasting glucose (≥100 mg/dl)
Male or female ≥21 and ≤60 years old
Must not have
A diagnosis of any type of diabetes or history of diabetes medication use
A prior use of Liraglutide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24weeks
Awards & highlights
Summary
This trial is studying whether exercise, liraglutide, or both can improve cardiac and skeletal muscle function in people with Metabolic Syndrome.
Who is the study for?
Adults aged 21-60 with Metabolic Syndrome, not currently very active, and have a stable weight (BMI between 25-35) can join. They must meet at least three criteria like large waist size, high triglycerides or blood sugar, low HDL cholesterol, or high blood pressure. Those on certain stable medications may also qualify.
What is being tested?
The study is testing the effects of exercise alone, the drug Liraglutide alone, and both combined on heart and muscle blood flow and insulin function in people with Metabolic Syndrome over 24 weeks. Participants will be randomly placed into one of four groups including a control group.
What are the potential side effects?
Possible side effects from Liraglutide include digestive issues like nausea or diarrhea; allergic reactions; headache; dizziness; increased heart rate. Exercise might cause muscle soreness or injury if not done properly.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I meet at least 3 of the 5 criteria for Metabolic Syndrome.
Select...
I am between 21 and 60 years old.
Select...
I am between 21 and 60 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have diabetes or have taken medication for it.
Select...
I have previously used Liraglutide.
Select...
I am currently smoking or quit smoking less than 5 years ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Microvascular Blood Volume - change from baseline
Secondary outcome measures
Augmentation Index - change from baseline
Flow Mediated Dilation
Insulin Sensitivity - change from baseline
+2 moreSide effects data
From 2017 Phase 4 trial • 100 Patients • NCT0201474029%
nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Liraglutide
Metformin
Trial Design
3Treatment groups
Experimental Treatment
Group I: Liraglutide AloneExperimental Treatment1 Intervention
24 weeks of treatment
Group II: Exercise AloneExperimental Treatment1 Intervention
24 weeks of treatment
Group III: Exercise + LiraglutideExperimental Treatment1 Intervention
24 weeks f treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liraglutide
2013
Completed Phase 4
~2680
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
771 Previous Clinical Trials
1,284,217 Total Patients Enrolled
5 Trials studying Metabolic Syndrome
478 Patients Enrolled for Metabolic Syndrome
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,431 Total Patients Enrolled
11 Trials studying Metabolic Syndrome
2,107 Patients Enrolled for Metabolic Syndrome
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,811 Total Patients Enrolled
35 Trials studying Metabolic Syndrome
2,860 Patients Enrolled for Metabolic Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes or have taken medication for it.You have been regularly doing intense exercise for at least 20 minutes, two times a week.You have very high levels of triglycerides or cholesterol in your blood.I meet at least 3 of the 5 criteria for Metabolic Syndrome.You have health conditions that prevent you from participating in an exercise program.I am between 21 and 60 years old.Your "good" cholesterol (HDL) is too low.You are allergic to perflutren.Your triglyceride levels are higher than 150 mg/dl.My medication doses have been stable for at least 3 months.Your body mass index (BMI) is between 25 and 35, and you haven't gained or lost more than 5 kilograms in the past 6 months. This is to make it easier for doctors to check your heart and blood vessels.I have been on stable doses of certain heart or cholesterol medications for at least 3 months.Your blood sugar level when you haven't eaten is higher than 100 mg/dl.I am taking an ACE inhibitor or ARB medication.Your waist measurement is larger than 102 cm (for men) or 88 cm (for women).You have high blood pressure, with readings of 130mmHg or higher for systolic pressure, or 85mmHg or higher for diastolic pressure.Your body mass index (BMI) is between 25 and 35, and you have not gained or lost more than 5 kilograms in the past 6 months.I have previously used Liraglutide.I am between 21 and 60 years old.I am taking a beta blocker medication.I am currently smoking or quit smoking less than 5 years ago.Your blood pressure is higher than 160/90.I have a history of serious health issues, including heart, lung, liver, kidney diseases, or another cancer.
Metabolic Syndrome Patient Testimony for trial: Trial Name: NCT04575844 — Phase 4
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